CN111543969A - Calibrating device of blood pressure measuring equipment - Google Patents

Abstract

The application relates to a verification device for blood pressure measurement equipment. The first pneumatic module includes a first air path interface, a voice coil motor, an air bag and a pressure sensor. When the verification device is used for blood pressure simulation, the pressure sensor will be detected The pressure information provided by the blood pressure device is fed back to the controller unit, the controller unit outputs the blood pressure pulse signal to the voice coil motor, and controls the voice coil motor to squeeze the airbag to simulate the blood pressure of the human body, and the airbag is connected to to the first air path interface; the second pneumatic module includes a second air path port, an air pump and a gas balance tank, the air pump generates a pulsed air flow under the control of the controller unit, and the pulse air flow passes through all the The gas balance tank is output to the second gas path interface. The invention avoids the error caused by the mechanical transmission system, establishes the traceability relationship between the blood pressure sample curve and the real human blood pressure signal, and can perform metrological verification on two types of sphygmomanometers.

Description

A kind of verification device for blood pressure measuring equipment

technical field

The present application relates to a medical measurement device, in particular to a verification device for a blood pressure measurement device.

Background technique

Non-invasive automatic measuring blood pressure monitor or multi-parameter monitor with blood pressure monitoring module is the main equipment to realize blood pressure measurement. Whether its measurement performance is qualified or not needs to be evaluated by non-invasive blood pressure verification device. Existing non-invasive blood pressure testing devices are mainly commercial non-invasive blood pressure simulators. By simulating the changes of the pulse wave during the measurement of human blood pressure, the performance evaluation of the non-invasive automatic measurement blood pressure monitor or blood pressure monitoring module based on the principle of oscillometric method is realized.

Existing verification devices with non-invasive blood pressure simulators often have multiple built-in blood pressure data curves to simulate changes in pulse waves during blood pressure measurement for different groups and different blood pressure indications. When the non-invasive blood pressure simulator is used for non-invasive blood pressure verification, it actually uses several calibration curves built in the simulator to evaluate the blood pressure measurement characteristics of the blood pressure monitor or blood pressure monitoring module. However, the sources of these calibration curves are different and there is no fixed standard, so it is difficult to directly establish the traceability relationship with the real human blood pressure indication, and its accuracy is difficult to measure. Therefore, the existing non-invasive blood pressure simulator cannot achieve true measurement traceability.

Existing verification devices with non-invasive blood pressure simulators mostly use a combination of stepper motor, lead screw, piston and cylinder. The stepper motor and lead screw control the movement of the piston in the cylinder to change the volume of the cylinder, thereby generating pressure pulses. Simulate the changes of pulse wave during human blood pressure measurement. However, the above-mentioned pulse generating device relies on a relatively complex mechanical transmission system, so it is difficult to avoid errors caused by the mechanical transmission system, and the response to the control signal sent by the controller is slow, so the blood pressure simulation process cannot be well restored.

Existing verification devices with non-invasive blood pressure simulators often have only one air path interface, which can only perform metrological verification on oscillometric-based single-cuff and single-catheter non-invasive automatic measurement sphygmomanometers or blood pressure monitoring modules. New non-invasive automatic measuring blood pressure monitor or blood pressure monitoring module with double catheter for metrological verification.

SUMMARY OF THE INVENTION

In view of the above problems, the present invention proposes a verification device for blood pressure measurement equipment, which eliminates the error caused by the mechanical transmission system by replacing the traditional stepping motor, lead screw, piston and cylinder with a voice coil motor and an airbag structure; The pneumatic system is redesigned, so that the verification device can verify both the single-cuff and single-catheter non-invasive automatic measurement sphygmomanometer or blood pressure monitoring module based on the traditional oscillometric method, and the new non-invasive automatic measurement of blood pressure or blood pressure with dual cuffs and dual catheters. Monitoring module: By collecting the blood pressure of the Chinese population and synchronously recording the pulse waveform signal, the Chinese human blood pressure standard data is formed and embedded in the verification device, the blood pressure sample curve is generated, and the traceability relationship between it and the real human blood pressure data is established.

Specifically, a first aspect of the present invention provides a blood pressure measurement device verification device, including: a first pneumatic module, a second pneumatic module and a controller unit; the first pneumatic module includes a first pneumatic system and a first pneumatic system. an air circuit interface, the second pneumatic module includes a second pneumatic system and a second air circuit interface; the first pneumatic system includes a voice coil motor, an air bag and a pressure sensor, when the verification device is used for blood pressure simulation, all The pressure sensor feeds back the pressure information provided by the blood pressure device to be tested to the controller unit, and the controller unit outputs the blood pressure pulse signal to the voice coil motor, and controls the voice coil motor to squeeze the airbag to simulate the human body blood pressure, the air bag is connected to the first air path interface; the second pneumatic system includes an inflator pump and a gas balance tank, the inflator pump generates a pulsed air flow under the control of the controller unit, and the pulsed air flow passes through the The gas balance tank is output to the second gas path interface.

Preferably, the airbag is provided with a first air release valve, the gas balance tank is provided with a second air release valve, and the controller unit controls the on-off of the first air release valve and the second air release valve.

Preferably, a solenoid valve is arranged between the air bag and the first air path interface, and the controller unit controls the on-off of the solenoid valve; the first air path port, the second air path port and the gas balance tank A two-way valve is arranged therebetween, and the controller unit controls the on-off of the two-way valve to communicate with the gas balance tank and the first gas path interface, or communicate with the gas balance tank and the second gas path interface.

Preferably, the airbag includes a first airbag and a second airbag, the first airbag communicates with the second airbag, and the first airbag is connected to the mover of the voice coil motor, and the second airbag Connected with the first air path interface, the controller unit controls the movement of the voice coil motor according to the blood pressure pulse signal, and the mover drives the first air bag to squeeze the second air bag, thereby simulating changes in human blood pressure.

Preferably, the first air bag is connected to the first fixing member, the mover of the voice coil motor is connected to the first fixing member and drives the first fixing member and the first air bag to move together; the second air bag is connected to the first fixing member. Two fixing pieces, the second fixing piece is fixed.

Preferably, the first airbag and the second airbag are hemispherical or truncated.

Preferably, a pinhole valve is further provided between the gas balance tank and the second gas path interface.

Preferably, the controller unit outputs the blood pressure pulse signal according to human blood pressure sample data.

Preferably, the verification device further includes a button and a display screen.

Preferably, the first airbag and the second airbag are bonded or integrally formed.

The blood pressure checking device provided by the invention can respond to the pulse signal faster, avoid errors caused by the mechanical transmission system, and restore the blood pressure simulation process better. In the verification device, the traceability relationship between the blood pressure sample curve and the real human blood pressure signal is established, and the carefully designed pneumatic system enables the user to simultaneously measure the oscillometric-based single-cuff and single-catheter non-invasive automatic measurement sphygmomanometer or blood pressure monitoring module, dual The new non-invasive automatic measurement sphygmomanometer or blood pressure monitoring module with double catheters is used for metrological verification.

Description of drawings

One or more embodiments are exemplified by the pictures in the corresponding drawings, and these exemplifications do not constitute limitations of the embodiments, and elements with the same reference numerals in the drawings are denoted as similar elements, Unless otherwise stated, the figures in the accompanying drawings do not constitute a scale limitation.

FIG. 1 is a system structure diagram of a non-invasive blood pressure testing device in an embodiment of the present invention;

2 is a schematic diagram of the whole machine of the non-invasive blood pressure testing device in the embodiment of the present invention;

FIG. 3 is a schematic diagram of the structure of the airbag of the non-invasive blood pressure testing device according to the embodiment of the present invention.

Controller Unit-1, Voice Coil Motor-2, Airbag-3, First Air Relief Valve-4, Pressure Sensor-5, First Air Line Interface-6, Solenoid Valve-7, Air Pump-8, Gas Balance Tank- 9. The second air relief valve-10, the two-way valve-11, the pinhole valve-12, the second air path interface-13, the button-14, the communication interface-15, the display screen-16, the casing-17, the first air bag -31, second airbag-32, first fixing piece-33, second fixing piece-34.

Detailed ways

Exemplary embodiments of the present application will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present application are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited by the embodiments set forth herein. Rather, these embodiments are provided so that the present disclosure will be more thoroughly understood, and will fully convey the scope of the present disclosure to those skilled in the art.

Existing non-invasive blood pressure simulators usually only have one external air path interface for connecting to a non-invasive automatic blood pressure monitor or a blood pressure monitoring module. Therefore, for some new non-invasive automatic measurement blood pressure monitors or blood pressure monitoring modules based on double cuffs and double catheters, the existing non-invasive blood pressure simulators are temporarily unable to perform metrological verification. The non-invasive blood pressure test device of the invention has a multi-channel pneumatic device, which can be used for the test of the traditional oscillometric method of a single-cuff and single-catheter non-invasive automatic measurement sphygmomanometer or a blood pressure monitoring module, and can be used for the new type of double-cuff and double-catheter. Non-invasive automatic measurement of sphygmomanometer or blood pressure monitoring module for verification, and can also realize non-invasive automatic measurement of sphygmomanometer or blood pressure monitoring module static pressure verification.

An embodiment of the present invention provides a verification device for a blood pressure measuring device. Referring to FIG. 1 , the verification device includes a first pneumatic module and a second pneumatic module, wherein the first pneumatic module includes a first pneumatic system and a first pneumatic system. Air circuit interface 6, the first pneumatic system includes a voice coil motor 2, an air bag 3, a first air relief valve 4 and a pressure sensor 5 for monitoring pressure changes in the air circuit, and also includes an air bag 3, a first air relief valve 4 and a pressure sensor 5. The hose that realizes the pneumatic connection between the sensors 5. The pressure sensor 5 , the voice coil motor 2 and the first air relief valve 4 are respectively electrically connected to the controller unit 1 . The second pneumatic module includes a second pneumatic system and a second air path interface 13 . The second pneumatic system includes an air pump 8 , a gas balance tank 9 , a second air relief valve 10 , and a hose for realizing the air path connection between them. Among them, the gas balance tank 9 in this embodiment is used to contain gas and help stabilize the pressure of the entire gas path (when the air pump 8 is pressed, gas will be introduced into the gas path from the outside of the system, and the gas volume in the entire gas path will increase. , the gas balance tank 9 is used to accommodate these gases), if the gas path channel leaks due to air tightness problems, the existence of the gas balance tank 9 will prevent the pressure of the entire gas path channel from fluctuating greatly, thus making the metrological verification will not be affected.

Referring to FIG. 2 , the first air path interface 6 and the second air path port 13 are exposed on the casing 17, wherein, when calibrating the oscillometric-based single-cuff single-catheter non-invasive automatic measurement sphygmomanometer or blood pressure monitoring module, the detected The device is connected to the first air path interface 6 through a hose, and at this time the first pneumatic system is used to simulate human blood pressure. When calibrating a dual-cuff dual-catheter sphygmomanometer, the upstream catheter of the sphygmomanometer to be tested is connected to the first air path interface 6 of the present invention, and the downstream catheter is connected to the second air path interface 13 of the present invention. At this time, the first pneumatic system and the The second pneumatic system works at the same time to complete the verification of the double-cuff double-catheter sphygmomanometer.

Further, the voice coil motor 2 in this embodiment is connected to the airbag 3 , the controller unit 1 outputs control pulses to the voice coil motor 2 according to the selected human blood pressure curve, and the voice coil motor 2 is driven under the control of the controller unit 1 . The airbag 3 moves back and forth, and the contraction and expansion of the airbag 3 cause changes in the internal air pressure, thereby simulating the blood pressure of the human body, and finally output to the sphygmomanometer through the first air path interface 6 . In this embodiment, the controller unit 1 is used to precisely control the voice coil motor 2, thus avoiding the use of a combination of a stepping motor, a lead screw, a piston and a cylinder to simulate human blood pressure, eliminating the error caused by the mechanical transmission system, and controlling The control signal sent by the controller unit 1 can directly drive the voice coil motor 2 to drive the airbag 3 to reciprocate, the response speed is faster, and the blood pressure simulation process can be better restored.

Furthermore, a solenoid valve 7 is arranged between the airbag 3 and the first air passage interface 6 , and a two-way valve 11 is arranged between the gas balance tank 9 and the first air passage interface 6 and the second air passage interface 13 . The solenoid valve 7 and the two-way valve 11 are both controlled by the controller unit 1 .

When the verification device of this embodiment is used for the measurement verification of the common traditional oscillometric non-invasive automatic measurement blood pressure monitor or blood pressure monitoring module, the device to be tested is connected to the first air path interface 6 external to the casing 17 through the hose. The solenoid valve 7 is opened to ensure that the air bag is connected to the air path of the first air path interface 6 , and the two-way valve 11 is now connected to the gas balance tank 9 and the second air path port 13 . When performing blood pressure simulation, the verification device selects the appropriate blood pressure sample curve, the pressure sensor 5 feeds back to the controller unit 1 according to the pressure information provided by the tested device, and the controller unit 1 outputs the blood pressure pulse signal to drive the voice coil motor to squeeze the airbag 3 to simulate the human body. The occurrence of blood pressure signals. The measured value of the blood pressure is calculated by measuring the air pressure change in the working process of the device under test.

When the verification device of this embodiment is used for the metrological verification of a new type of non-invasive automatic measurement sphygmomanometer or blood pressure monitoring module based on dual cuffs and dual catheters, it is necessary to connect the dual catheters of the device to be tested and the two external air circuits of the present invention The interface corresponds to the connection. The specific connection method is related to the blood pressure measurement method of the tested device. Generally, for a sphygmomanometer that is divided into upstream/downstream conduits, the upstream conduit can be connected to the first air conduit interface 6 of this embodiment, and the downstream conduit can be connected to the second air conduit interface 13 of this embodiment. . At this time, the solenoid valve 7 is opened to ensure that the air bag 3 is connected to the air path of the first air path port 6 , and the two-way valve 11 is now connected to the gas balance tank 9 and the second air path port 13 . When the verification device is used for blood pressure simulation, select the appropriate blood pressure sample curve as needed, and the pressure sensor 5 outputs the appropriate pulse signal to the voice coil motor under the control of the controller unit 1 according to the detected pressure indication provided by the device under test. 2. The voice coil motor 2 squeezes the airbag 3 under the control of the controller unit 1 to generate a pulse signal. When the device under test enters the deflation stage, the pressure drops, and the air pump 8 gradually generates a pulsed air flow under the control of the controller unit 1 and transmits it to the second air path interface 13 . The first pneumatic system and the second pneumatic system work together to reproduce the changing states of the blood pressure signals of different pipelines during the blood pressure measurement process of the device under test.

When the verification device of this embodiment is used for the non-invasive automatic measurement of sphygmomanometer or the verification of the static pressure of the blood pressure monitoring module, the device to be tested is connected to the first air path interface 6 outside the casing 17 of the verification device through a hose (it should be pointed out that The thing is, for some new sphygmomanometers, when the static pressure is checked, the two air circuit interfaces can also be connected with hoses respectively), the solenoid valve 7 is closed at this time, that is, the first air circuit interface 6 and the air bag 3 are in the closed state. The two-way valve 11 connects the gas balance tank 9 and the first gas path interface 6 at this time. The air pump 8 inflates and pressurizes according to the pressure value set by the controller unit 1 to detect and complete the measurement at the end of the device under inspection.

The gas path switching design of the solenoid valve 7 and the two-way valve 11 in this embodiment makes the hose of the tested equipment do not need to be pulled out from the first air path interface 6 and then installed to The second gas path interface 13 simplifies the steps of the verification operation and facilitates the use of the user.

Further, the airbag 3 is preferably made of silica gel. However, the expansion and contraction deformation of a single silicone airbag 3 is not easy to control, and it may cause deformation in the non-axial direction, which makes it impossible to evaluate the expansion and contraction of the airbag 3 only by the expansion and contraction of the mover of the voice coil motor 2, so it is impossible to accurately evaluate the expansion and contraction of the airbag 3 Simulates human blood pressure. In order to accurately control the deformation of the airbag 3, preferably, the airbag 3 includes a first airbag 31 and a second airbag 32, the first airbag 31 is communicated with the second airbag 32, and optionally, the two airbags are bonded together A through hole is provided between the two airbags, or the two airbags are integrally formed and communicated through the through hole. The first air bag 31 is coaxially connected to the mover of the voice coil motor 2, the second air bag 32 is communicated with the first air path interface 6, and the controller unit 1 controls the voice coil motor 2 according to the blood pressure pulse signal The mover moves, and the mover drives the first air bag 31 to squeeze the second air bag 32, thereby simulating changes in human blood pressure.

Furthermore, since the first airbag 31 itself is relatively soft and the diameter of the airbag is larger than that of the mover of the voice coil motor 2 , the effect of directly pressing the first air bag 31 by the mover of the voice coil motor 2 is not good. Preferably, a first fixing member 33 is provided on the first air bag 31 , the diameter of the first fixing member 33 is close to the diameter of the first air bag 31 , and the mover of the voice coil motor 2 is connected to the first fixing member 33 , thereby Under the control of the controller unit 1, the first fixing member 33 and the first air bag 31 are driven to move together. Preferably, the second air bag 32 is provided with a second fixing member 34 , the diameter of the second fixing member 34 is close to the diameter of the second air bag 32 , and the second fixing member 34 is fixed and immovable, so that the first air bag 31 squeezes the first air bag 31 . When the second air bag 32 is used, it plays the role of blocking the movement of the second air bag 32 .

The split airbag structure of this embodiment overcomes the defect of non-axial deformation caused by a single airbag structure, so that the shape change of the airbag is easy to control, and the change of human blood pressure can be simulated more accurately.

Furthermore, a pinhole valve 12 is also embedded in the connecting gas pipe of the gas balance tank 9 and the second gas path interface 13 . The pinhole valve 12 can effectively reduce the inner diameter of the trachea and increase the impact capability of the air flow in the air path, so as to transmit the air pressure change to the tested equipment in a timely manner, and improve the blood pressure simulation performance of the testing device.

Further, the controller unit 1 is also connected with peripheral devices such as buttons 14, a communication interface 15, a display screen 16, etc., so that the user can realize the debugging, setting and data of the verification device through these peripheral devices exposed on the casing 17. read.

Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present application, but not to limit them; although the present application has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: it can still be The technical solutions described in the foregoing embodiments are modified, or some technical features thereof are equivalently replaced; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions in the embodiments of the present application.

Claims (10)

1. An assay device for blood pressure measurement equipment, comprising:

a first pneumatic module, a second pneumatic module and a controller unit;

the first pneumatic module comprises a first pneumatic system and a first gas circuit interface, and the second pneumatic module comprises a second pneumatic system and a second gas circuit interface;

the first pneumatic system comprises a voice coil motor, an air bag and a pressure sensor, when the calibrating device is used for blood pressure simulation, the pressure sensor feeds back pressure information provided by a detected blood pressure device to the controller unit, the controller unit outputs a blood pressure pulse signal to the voice coil motor, the voice coil motor is controlled to extrude the air bag to simulate the blood pressure of a human body, and the air bag is connected to the first air path interface;

the second pneumatic system comprises an inflator pump and a gas balance tank, the inflator pump generates pulse airflow under the control of the controller unit, and the pulse airflow passes through the gas balance tank and then is output to the second gas path interface.

2. The calibrating apparatus for blood pressure measuring equipment according to claim 1, wherein a first air release valve is disposed on the air bag, a second air release valve is disposed on the air balance tank, and the controller unit controls the on/off of the first air release valve and the second air release valve.

3. The calibrating device for blood pressure measuring equipment according to claim 1, wherein an electromagnetic valve is arranged between the air bag and the first air passage interface, and the controller unit controls the on-off of the electromagnetic valve; and a two-way valve is arranged between the first gas path interface, the second gas path interface and the gas balancing tank, and the controller unit controls the on-off of the two-way valve so as to communicate the gas balancing tank with the first gas path interface or communicate the gas balancing tank with the second gas path interface.

4. The calibrating apparatus for blood pressure measuring equipment according to claim 1, wherein the air bag comprises a first air bag and a second air bag, the first air bag is communicated with the second air bag, the first air bag is connected with a mover of the voice coil motor, the second air bag is communicated with the first air path interface, the controller unit controls the mover of the voice coil motor to move according to the blood pressure pulse signal, and the mover drives the first air bag to press the second air bag, so as to simulate the blood pressure change of the human body.

5. The calibrating device for blood pressure measuring equipment according to claim 4, wherein the first air bag is connected to a first fixing member, and the rotor of the voice coil motor is connected to the first fixing member and drives the first fixing member and the first air bag to move together; the second airbag is connected to a second fixing piece, and the second fixing piece is fixed.

6. The calibrating device for a blood pressure measuring apparatus according to claim 4 or 5, wherein the first balloon and the second balloon are hemispherical or circular truncated cone shaped.

7. The calibrating device for blood pressure measuring equipment according to any one of claims 1-4, wherein a pinhole valve is further disposed between the gas balancing tank and the second gas path interface.

8. The verification device of blood pressure measurement equipment according to claim 1, wherein the controller unit outputs the blood pressure pulse signal according to human blood pressure sample data.

9. The calibrating device for a blood pressure measuring apparatus according to claim 1, wherein the calibrating device further comprises a key and a display screen.

10. The verification device for blood pressure measurement equipment according to claim 4 or 5, wherein the first and second air cells are bonded or integrally formed.

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